Phase II Study Evaluating Busulfan and Fludarabine as Preparative Therapy in Adults With Hematopoietic Disorders Undergoing MUD SCT
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ClinicalTrials.gov Identifier: NCT00516152 |
Recruitment Status :
Completed
First Posted : August 15, 2007
Last Update Posted : January 26, 2009
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Condition or disease | Intervention/treatment | Phase |
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Chronic Myeloid Leukemia Acute Myelogenous Leukemia Myelodysplasia Acute Lymphocytic Leukemia Severe Aplastic Anemia Non-Hodgkin's Lymphoma Lymphoproliferative Disease Multiple Myeloma Advanced Myeloproliferative Disease | Drug: Busulfan/Fludarabine phosphate/Tacrolimus/Methotrexate/G-CSF | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 36 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase II Study Evaluating Busulfan and Fludarabine as Preparative Therapy in Adults With Hematopoietic Disorders Undergoing Matched Unrelated Donor Stem Cell Transplantation |
Study Start Date : | November 2002 |
Actual Study Completion Date : | November 2007 |

- Drug: Busulfan/Fludarabine phosphate/Tacrolimus/Methotrexate/G-CSF
Day Preparative Regimen for GVHD Prophylaxis
- 7 Busulfan 0.8 mg/kg IV Q6 hurs, Fludarabine 30 mg/m(2)IV
- 6 Busulfan 0.8 mg/kg IV Q6 hurs, Fludarabine 30 mg/m(2)IV
- 5 Busulfan 0.8 mg/kg IV Q6 hurs, Fludarabine 30 mg/m(2)IV
- 4 Busulfan 0.8 mg/kg IV Q6 hurs, Fludarabine 30 mg/m(2)IV
- 3 Fludarabine 30 mg/m(2)IV
- 2 REST Tacrolimus 0.01 mg/kg CIVI
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1 REST 0 Unrelated Stem Cell/Bone Marrow Infusion
- 1 Methotrexate 5mg/m(2)IV
- 3 Methotrexate 5mg/m(2)IV
- 6 Methotrexate 5mg/m(2)IV
- 7 G-CSF 5mcg/kg SQ daily
- 11 Methotrexate 5mg/m(2)IV
- 90 Evaluate Response

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Ages Eligible for Study: | 15 Years to 61 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- No fully or single-antigen mismatched sibling donor is available to donate stem cells.
- Age >15 and <61
- ECOG PS < or equal to 2
- Adequate renal function with serum creatinine <2.0 mg/dl
- Pulmonary diffusing capacity >40% of predicted
- Cardiac ejection fraction >40% as measured by radionuclide wall motion study or echocardiography
- No active liver disease. Total bilirubin must be < or equal to 2.0 mg/dl. Alkaline phosphatase and AST must be less than three times the upper limit of normal. Patients with hepatitis C and active hepatitis B are eligible only if a liver biopsy is performed and there is < or equal to grade 2 inflammation. Patients wtih a history of HBV infection should be tested for HBeAg, antiHBe and HBV DNA (quantitative). Patients with active HBV viral replication should receive anti-viral therapy.
- Negative serology for the human immunodeficiency virus (HIV)
- Available HLA-matched donor (see HLA compatibility requirements below)
- Signed informed consent from the recipient
Exclusion Criteria:
- Ongoing active infection
- Pregnancy and/or nursing
- Active, uncontrolled CNS leukemia
- Opinion of BMT Committee that autologous or mini-allogeneic transplant would be the preferable form of treatment
- Receipt of any chemotherapy within 3 weeks of study entry except for hydroxyurea or imatinib mesylate. Use of interferon within 3 months of starting therapy.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00516152
United States, California | |
University of California San Francisco | |
San Francisco, California, United States, 94143 |
Principal Investigator: | Thomas G. Martin, M.D. | University of California, San Francisco |
Responsible Party: | Beth Davis, University of California San Francisco |
ClinicalTrials.gov Identifier: | NCT00516152 |
Other Study ID Numbers: |
UC-2214 |
First Posted: | August 15, 2007 Key Record Dates |
Last Update Posted: | January 26, 2009 |
Last Verified: | January 2009 |
Matched Unrelated Donor Stem Cell Transplantation Busulfan fludarabine Hematopoietic Disorder |
Leukemia Multiple Myeloma Leukemia, Myeloid Leukemia, Myelogenous, Chronic, BCR-ABL Positive Leukemia, Myeloid, Acute Precursor Cell Lymphoblastic Leukemia-Lymphoma Anemia, Aplastic Myeloproliferative Disorders Lymphoproliferative Disorders Neoplasms by Histologic Type Neoplasms Neoplasms, Plasma Cell Hemostatic Disorders Vascular Diseases Cardiovascular Diseases |
Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Immunoproliferative Disorders Immune System Diseases Lymphatic Diseases Leukemia, Lymphoid Bone Marrow Diseases Anemia Bone Marrow Failure Disorders Methotrexate Fludarabine phosphate Fludarabine Busulfan |